Hecker & Associates, Llc

Hecker & Associates, LLC, is a drug development consulting group started in July 2001, strategizing for and managing production of global drug and biologic drug development projects, through cost- and time-efficient clinical trial and marketing applications. Sandy'smore than 20 years of pharmaceutical and biotech industry experience enables her to guide clients through the US and Canadian regulatory pathway appropriately and efficiently. Sandy identifies data and documentation "red-flags" before her client's submissions are filed, so the problems can be explained/eliminated, minimizing the number of regulatory agency questions about the application, assuring a good working relationship between her client and the regluatory agency, thus hastening the time to market for a successful drug. She has a special interest in helping companies implement and comply with the International Conference on Harmonisation (ICH) Common Technical Document (CTD) guidance and with INDs in electronic CTD format. Sandy also helps companies meet drug safety/pharmacovigilance requirements in the US, Canada, and Europe, as well as assists her clients assess potential new acquisitions, and out licensing opportunities through her regulatory "due diligence" work. In addition she supports a US immigration lawyer by writing "expert witness" letters for his clients who are in the pharmaceutical industry elsewhere in the world, and want to move to the United States.